…the original records”); and §§ 211.188, 211.194, and 212.60(g) (requiring “complete information,” “complete data derived from all tests,” “complete record of all data,” and “complete records of all tests performed”)….

…(“CSA”), qualified practitioners can prescribe, administer or dispense buprenorphine products for the treatment of opioid use disorder in an office, community hospital, health department or correctional facility. 21 U.S.C. §…

…allegedly been overwritten. They also concluded that they found multiple instances of trial injections of samples, where the final tests were recorded, but the original results had apparently not been….

…a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. See, e.g., 21 C.F.R. § 1306.04(a). The same is true for action against…

…July 2012 is not unconstitutional.  The Court succinctly (and with a little snark) captures its decision in a concluding paragraph: The parties agree that the Alameda County Safe Drug Disposal…

…ruled that federal law does not preempt state-law design defect claims concerning generic drug products because any conflict between federal and state law can be avoided if the the generic…

…occur in FDA’s user fee programs. While Congress did allow for some exemptions from fiscal year limitations and for some amounts to be carried forward into subsequent fiscal years, it…

…additional designation requests for the drug to cover these additional indication(s) or use(s) – because they would fall within the original designation.  Additional orphan-drug exclusivity may attach upon approval of…

…particular clinical trial is an “applicable drug clinical trial” under Title VIII of PL 110‐85 (section 402(j)(1)(A)(iii) of the PHS Act).  Although Phase 1 clinical investigations are generally designed to…

…the difference between the Federal Ceiling Price and either (a) the most recent annual non-Federal average manufacturer price (“Non-FAMP”) reported to the VA, or (b), at the manufacturer’s option, “direct…

…right? And, in any case, having delayed pulling together this post, we now have the benefit of some rather interesting statistics and information from FDA’s Fiscal Year 2020 Justification of…

…obtained and the trial concluded. Further, international standards for medical research require trial sponsors to allow participants to access the studied treatment even after the trial’s conclusion. The Court here…

…Spring because the annual American Conference Institute (“ACI”) “Paragraph IV Disputes” conference is right around the corner. That’s right, ACI will be holding its 13th annual “Paragraph IV Disputes” conference…

…Contrast this with Paragraph IV 180-day exclusivity, which blocks the approval of a subsequent applicant after a first applicant has submitted an application containing a Paragraph IV certification thereby preserving…

…medical problems arising during participation in the trial, reasonable access to medical care, and attention to protocol violations that can expose study subject to unreasonable risks. By Noelle C. Sitthikul…